Press Release
Sep 10, 2024
(San Diego, Calif.--September 10, 2024, 10:35 a.m. PCT) — The ROS1 tyrosine kinase inhibitor taletrectinib demonstrated high and durable overall responses, robust intracranial activity, and a favorable safety profile with low incidence of neurologic adverse events in tyrosine kinase inhibitor-naive and TKI-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC).
These results were presented today at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer by Dr. Geoffrey Liu, from Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto, Canada.
ROS-1 fusions occur in approximately 1 to 2 percent of all non-small cell lung cancers and occur when the ROS-1 gene attaches to another gene that results in uncontrolled cell growth and tumors.
In the Phase I study, TRUST-1, taletrectinib demonstrated high overall and intracranial response rates, prolonged progression-free survival, and activity against the ROS1G2032R acquired resistance mutation with favorable tolerability.
Dr. Liu today presented updated Phase II results in TKI-naive and TKI-pretreated patients from TRUST-II, evaluating the efficacy and safety of taletrectinib in patients with advanced ROS1+ NSCLC.
TRUST-II is a global, multicenter, single-arm study of taletrectinib 600 mg once daily in patients with ROS1+ tumors that included two cohorts: Cohort 1 consisted of patients who were TKI naive with ≤1 line of chemotherapy while Cohort 2 consisted of patients who were pretreated with 1 prior ROS1 TKI and ≤1 line of chemotherapy.
The primary endpoint was confirmed objective response rate, and key secondary endpoints included duration of response, progression-free survival, and safety.
|
|
Cohort 1: 54 Patients, TKI naive, ≤1 line of chemotherapy |
Cohort 2: 49 Patients, TKI pretreated, 1 prior ROS1 TKI and ≤1 line of chemotherapy. |
|
Baseline Brain Metastases |
33 % |
55 % |
|
Prior Chemotherapy |
17 % |
33 % |
|
Prior Crizotinib |
NA |
82 % |
|
Prior Enectrinib |
NA |
18 % |
|
Confirmed ORR |
87 (95% CI: 74-94) % |
55 (95% CI: 39-70) % |
|
Intracranial ORR |
75 (95% CI: 35-97) % |
56 (95% CI: 30-80) % |
|
12-Month DOR |
80 % |
75 % |
|
Median PFS |
Not reached |
11.9 months |
|
Common Adverse Effects (all grades, %) |
Increased ALT (66), Increased AST (65), Diarrhea (52) |
Increased ALT (66), Increased AST (65), Diarrhea (52) |
"Taletrectinib continues to demonstrate high and durable overall responses, robust IC activity, and a favorable safety profile with low incidence of neurologic AEs in both TKI-naive and TKI-pretreated patients with ROS1+ NSCLC," said Dr. Liu. "The efficacy and safety of taletrectinib in TRUST-II remains highly consistent with TRUST-I."
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About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.
About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration, and understanding of lung cancer and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2024.iaslc.org.